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DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE & MEDICAID SERVICESForm Approved OMB No. 09380581CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) APPLICATION FOR CERTIFICATION I.

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This is known as Clinical Laboratory Improvement Amendments of 1998 (CLIA) certification. Your CLIA number must be submitted on claims for clinical laboratory tests, including tests that are classified as 'CLIA-waived. ' Submit this information in Loop 2300 or 2400, REF/X4, 02 for electronic claims.

3. What is waived testing? By the CLIA law, waived tests are those tests that are determined by CDC or FDA to be so simple that there is little risk of error. Some testing methods for glucose and cholesterol are waived along with pregnancy tests, fecal occult blood tests, some urine tests, etc.

The specific tests that are deemed to be CLIA waived are: Non-automated urinalysis using dipstick or tablet reagents. Ovulation tests. Urine pregnancy tests. Fecal occult blood. Hemoglobin-copper sulfate. Erythrocyte sedimentation rate. Blood glucose monitoring utilizing devices specifically for home use. Spun microhematocrit.

Waived tests are simple, one-step tests approved by CLIA for use in a physician's office laboratory. The government requires a certificate of waiver to perform waived tests. Some waived tests include glucose monitoring, urine dipstick analysis, pregnancy testing, and fecal occult blood packets.

What is a Waived Test? Based on the complexity of the tests, CLIA tests are categorized into three levels: waived, moderate complexity, and high complexity tests. CLIA defines waived tests as “Simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.”

As defined by CLIA, waived tests are “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” Examples of waived tests include: dipstick urinalysis, fecal occult blood, urine pregnancy tests, and blood glucose monitoring.

CLIA-waived testing, such as Point of Care Testing, are low complexity tests (including Hemoglobin and Hematocrit) that may be performed by other personnel with proper training.

The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232